Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

This is a Phase 1, single-center, open-label study designed to evaluate the safety and PK
profile of EXAPREL when administered intraoperatively at the end of surgery via local
infiltration. Fifteen pediatric subjects 12 to less than 17 years of age undergoing spinal
surgeries are planned for enrollment.

Subjects will be screened within 30 days prior to study drug administration. During the
screening visit, subjects will be assessed for past or present neurologic, cardiac, and
general medical conditions that, in the opinion of the investigator, would preclude them from
study participation.

Subjects will undergo their pre-planned spinal surgeries per the institution's standard of
care. On Day 1, eligible subjects will receive a single dose of EXPAREL 4 mg/kg
intraoperatively at the end of surgery via local infiltration into the surgical site. There
is no required length of stay in the hospital; subjects may be discharged based on the
medical judgment of the treating physician.

A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit
will be made on Day 30 to all subjects who received study drug.

Inclusion Criteria:

1. Subjects whose parent(s) or guardian(s) has/have signed and dated an informed consent
form for the subject to participate in the study, and subjects who have provided
written assent to participate in the study (if capable).

2. American Society of Anesthesiologists (ASA) Class 1-3.

3. Male or female subjects 12 to less than 17 years of age on the day of surgery.

4. Body mass index (BMI) at screening within the 20th to 80th percentile for age and sex.

5. A pregnancy test for female subjects of childbearing potential will be conducted in
the preoperative holding area according to the study site's standard of care. A
negative result for the pregnancy test must be available prior to the start of
surgery.

6. Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand
the language of the ICF and any instruments used for collecting subject-reported
outcomes in order to enable accurate and appropriate responses to study assessments,
and provide informed consent/assent.

7. Subjects must be able to adhere to the study visit schedule and complete all study
assessments.

Exclusion Criteria:

1. Contraindication to bupivacaine or other amide-type local anesthetics or to opioid
medication.

2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug
administration.

3. Subjects with coagulopathies or immunodeficiency disorders.

4. Administration of an investigational drug within 30 days or 5 elimination half-lives
of such investigational drug, whichever is longer, prior to study drug administration,
or planned administration of another investigational product or procedure during the
subject's participation in this study.

In addition, the subject will be ineligible to receive study drug if the following
criterion is met during surgery:

5. Any clinically significant event or condition uncovered during the surgery (eg,
excessive bleeding, acute sepsis) that might render the subject medically unstable or
complicate the subject's postsurgical course.